<b>Bijsluiter</b>. De hyperlink naar het originele document werkt niet meer. Daarom laat Woogle de tekst zien die in dat document stond. Deze tekst kan vreemde foutieve woorden of zinnen bevatten en de opmaak kan verdwenen of veranderd zijn. Dit komt door het zwartlakken van vertrouwelijke informatie of doordat de tekst niet digitaal beschikbaar was en dus ingescand en vervolgens via OCR weer ingelezen is. Voor het originele document, neem contact op met de Woo-contactpersoon van het bestuursorgaan.<br><br>====================================================================== Pagina 1 ======================================================================

<pre>Gezondheidsraad                               Voorzitter
Health Council of the Netherlands
Aan de Staatssecretaris van Sociale Zaken en Werkgelegenheid
Onderwerp            : Aanbieding adviezen herevaluatie bestuurlijke MAC-waarden
Uw kenmerk           : ARBO/AMIL/97/00648
Ons kenmerk          : U 2706/CB/MP/563-O3
Bijlagen             : 18
Datum                : 14 december 2000
Mijnheer de staatssecretaris,
Op verzoek van uw ambtsvoorganger bied ik u hierbij de eerste adviezen aan van een
reeks over de gezondheidskundige basis van uit het buitenland overgenomen
grenswaarden voor beroepsmatige blootstelling aan stoffen. Het verzoek om deze
adviezen is in algemene zin vervat in brief nr ARBO/AMIL/97/00648 en in latere stadia
door uw departement toegespitst op afzonderlijke stoffen. De adviezen zijn opgesteld
door een daartoe door mij geformeerde internationale commissie van de Gezondheidsraad
en beoordeeld door de Beraadsgroep Gezondheid en Omgeving.
     De beoogde reeks van in het Engels gestelde adviezen zal losbladig worden
gepubliceerd onder ons publicatienummer 2000/15OSH en, conform de aan de
Gezondheidsraad voorgelegde toespitsingen van de adviesaanvraag, betrekking hebben
op 168 stoffen. Het u thans aangeboden eerste pakket bestaat uit een Algemene Inleiding
(publicatienummer 2000/15OSH/000) en uit de adviezen genummerd 2000/15OSH/001
tot en met 2000/15OSH/017, respectievelijk betrekking hebbend op:
cesiumhydroxide, cyclopentaan, diboraan, dimethoxymethaan, dipropylketon,
fenylfosfine, germaniumtetrahydride, hexachloornaftaleen, methaanthiol,
methylcyclohexanol, methylisopropylketon, mica, natriumhydroxide,
octachloornaftaleen, silaan, tetrachloornaftaleen, en yttrium en yttriumverbindingen.
     Bij afronding van de werkzaamheden van de hierboven bedoelde commissie ontvangt
u een Nederlandstalige samenvatting van de in de gehele reeks van adviezen neergelegde
bevindingen.
Bezoekadres                                                                  Postadres
Parnassusplein 5                                                             Postbus 16052
2511 VX Den Haag                                                             2500 BB Den Haag
Telefoon (070) 340 75 20                                                     Telefax (070) 340 75 23
email: GR@gr.nl
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<pre>Gezondheidsraad
Health Council of the Netherlands
Onderwerp            : Herevaluatie uit het buitenland overgenomen grenswaarden
Ons kenmerk          :U
Pagina               :2
Datum                : 14 december 2000
    De u thans aangeboden adviezen heb ik vandaag ter informatie doen toekomen aan
de Minister van Volksgezondheid, Welzijn en Sport en aan de Minister van
Volkshuisvesting, Ruimtelijke Ordening en Milieubeheer.
Hoogachtend,
prof. dr JJ Sixma
Bezoekadres                                                                   Postadres
Parnassusplein 5                                                              Postbus 16052
2511 VX Den Haag                                                              2500 BB Den Haag
Telefoon (070) 340 75 20                                                      Telefax (070) 340 75 23
email: GR@gr.nl
</pre>

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<pre>      Diborane
      (CAS Reg. nr: 19287-45-7)
      Health-based Reassessment of Administrative
      Occupational Exposure Limits
      Committee on Updating of Occupational Exposure Limits,
      a committee of the Health Council of the Netherlands
      No. 2000/15OSH/003, The Hague, 14 December 2000
003-1
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<pre>      Preferred citation:
      Health Council of the Netherlands: Committee on Updating of Occupational
      Exposure Limits. Diborane; Health-based Reassessment of Administrative
      Occupational Exposure Limits. The Hague: Health Council of the Netherlands,
      2000; 2000/15OSH/003.
      all rights reserved
003-2
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<pre>1     Introduction
      The present document contains the assessment of the health hazard of diborane
      by the Committee on Updating of Occupational Exposure Limits, a committee
      of the Health Council of the Netherlands. The first draft of this document was
      prepared by AAE Wibowo, Ph.D. (Coronel Institute of the Academic Medical
      Centre, Amsterdam, the Netherlands).
           Literature was retrieved from the data bases Medline, Embase, Toxline and
      Chemical Abstracts, starting from 1966, 1988, 1967 and 1970, respectively,
      and using the substance name as a key word. Also Current Contents (from
      1997 backwards) and the CD-roms HSEline, Cisdoc, Mhidas and NIOSHtic
      were consulted (from 1997 backwards). Data considered to be critical were
      evaluated by reviewing the original publications. The final literature search has
      been carried out in October 1997.
           In March 2000, the President of the Health Council released a draft of the
      document for public review. Comments were received by the following
      individuals and organizations: L Whitford (Health & Safety Executive,
      London, United Kingdom), dr P Wardenbach (Bundesanstalt für Arbeitsschutz
      und Arbeitsmedizin, Dortmund, Germany). These comments were taken into
      account in deciding on the final version of the document.
2     Identity
       name                              :    diborane
       synonyms                          :    diboraan (Dutch) boroethane
                                              diboron hexahydride
       molecular formula                 :    B2H6
       structural formula                :    H3BBH3
       CAS reg nr                        :    19287 - 45 - 7
003-3 Diborane
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<pre>3     Physical and chemical properties
       molecular weight                   :     27.7
       boiling point                      :     -92.50C
       melting point                      :     -1650C
       relative vapour density (air=1)    :     0.96
       solubility in water                :     hydrolizes to hydrogen and boric acid
       log Poct/water                     :      -
       conversion factors                       1 mg/m3 = 0.87 ppm
       (20oC, 101.3 kPa)                        1 ppm = 1.15 mg/m3
      Data from IPC93.
      Diborane is a flammable gas with a repulsive, sickly-sweet odour. It is also
      described as having an odour of ‘rotten eggs’. The median odour threshold was
      3.7 mg/m3 (range 3.3 - 4.2 mg/m3) (Com53). The American Industrial Hygiene
      Association reported a range of 2.1 - 4.0 mg/m3 (1.8 - 3.5 ppm) for the odour
      threshold (AIH89).
4     Uses
      Diborane is used as a selective reducing agent, initiator of rubber
      vulcanization, bactericide, fungicide, initiator of ethylene, vinyl, styrene and
      acrylic polymerization (Rou59), high energy rocket propellant (Uem95) and as
      a boron source in the production of integrated circuits in the semiconductor
      industry (Nom96).
5     Biotransformation and kinetics
      The International Programme on Chemical Safety (IPCS) of the World Health
      Organisation reported that occupational exposure may occur by inhalation
      (IPC93).
            Diborane is a very reactive gas. In contact with air, a small quantity of
      diborane is converted to higher hydrides, pentaborane and decaborane (Rou59).
      In an aquaous environment, diborane hydrolizes to form boric acid and
      hydrogen. Due to its chemical and physical characteristics, the upper
003-4 Health-based Reassessment of Administrative Occupational Exposure Limits
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<pre>      respiratory tract and the lungs are the target organs of occupational exposure to
      diborane.
          There is no data on absorption, distribution, metabolism and excretion of
      the compound. It is conceivable that some diborane may be absorbed (Rou59).
6     Effects and mechanism of data
      Human data
      There is no data on irritation and sensitization nor epidemiological data
      available on exposure to diborane. Only a few case-reports have been described.
          Rousch Jr. reported that men working with diborane had similar complaints
      as cough, tightness in the chest and occassionally also headache (Rou59). The
      symptoms concerned the respiratory tract and were non-specific.
          In health risk assessment of diborane, concomitant exposure to pentaborane
      and decaborane should be taken into account. Penta- and decaborane differ
      from diborane in that they affect the central nervous system rather than the
      pulmonary system (Wil85), giving rise to dizziness, drowsiness and headache
      as early symptoms (Low57). Decaborane has also been found to cause damage
      to the liver and kidneys (Sch58).
          Lowe and Freeman (Low57) reported a case of accidental exposure to
      diborane. Five and a half hours after the accident the worker developed
      light-headedness and hiccups, followed by nausea and drawsiness. The
      following day the drawsiness persisted and the muscles of both thighs became
      painful and began to shake. On admission to hospital, diaphoresis was profuse
      and photophobia was evident. Neurological examination revealed no
      abnormalities. On the following days his condition improved and he was
      discharged seven days after exposure.
          Cordasco et al. (Cor68) described a patient who was acutely exposed to
      diborane fumes through an unprovoked explosion. He developed shortness of
      breath, vertigo and dry cough. After being given oxygen (by mask) he obtained
      relief 20 minutes later. Six days later, the dry cough recurred after the patient
      was again exposed to diborane and he developed concomitant generalized chest
      tightness. Chest x-ray examination demonstrated a pneumonitis at both bases.
      Animal data
      No data on irritation or sensitization of diborane were found.
003-5 Diborane
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<pre>          Schechter (Sch58) reported an LC50 of diborane in rats of 92 mg/m3 (80
      ppm) after a 4 hour exposure period. Pentaborane and decaborane were more
      toxic than diborane, having LC50s of 6.8 and 45.5 ppm respectively. More
      recently, Uemura et al. (Uem95) reported an LC50 of 36.2 mg/m3 (31.5 ppm)
      for diborane in mice after 4 hour exposure and observation during 2 weeks.
          Uemura et al. (Uem95) performed an experiment in which groups (n=10)
      of male ICR mice were exposed by inhalation to 17.3 mg/m3 (15 ppm) diborane
      for 1, 2, 4 or 8 hours, and observed during 3 days. In the 8-hour exposure
      group the reaction of the mice to noise was decreased. Ruffled fur and systemic
      tremors were observed in some of the animals. Body weights were significantly
      decreased 1 and 2 days after exposure, and significant increases in absolute
      lung and trachea weights were found. No changes were observed on
      hematological and biochemical parameters. Severe inflammatory changes were
      found in the lungs of the exposed groups in an exposure duration-related
      manner. The lesions were similar to diffuse panbronchiolitis in human cases.
          Nomiyama et al. (Nom95a) exposed groups (n=10) of male ICR mice to 1.2
      mg/m3 (1 ppm) or 5.8 mg/m3 (5 ppm) diborane by inhalation during 1, 2, 4 or 8
      hours. Within the group exposed to 5.8 mg/m3 lung weights (both absolute and
      relative) were increased. However, lung weights were significantly decreased in
      the group exposed to 1.2 mg/m3. Diffuse panbronchiolitis-like obstructive
      changes were observed in the lungs of the mice exposed to 5.8 mg/m3, and this
      response was dose- and exposure duration-related. In this experiment a
      no-observed adverse effect level (NOAEL) in mice of 1.2 mg/m3 (1 ppm)
      diborane (for an 8-hour exposure) was found.
          Nomiyama et al. (Nom95b) also exposed groups (n=8) of male Wistar rats
      to 23 mg/m3 (20 ppm) diborane for 4 hours and they evaluated time-course
      changes up to 14 days post exposure. Examination of the bronchoalveolar
      lavage fluid (BALF) showed increases of neutrophils on the day of exposure,
      followed by gradual decreases for the next three days. Rapid marked increases
      of α1-antitrypsin and superoxide dismutase activities were detected in the
      BALF on the day of exposure, and phospholipids had sharply increased on day
      3. After 14 days these parameters returned to their background levels. The
      authors also studied groups (n=12) of rats exposed to 1.2 or 11.5 mg/m3 (1 or
      10 ppm) diborane for 4 hours to assess the dose-effect relationship after 3 days.
      In this study total protein, α1-antitrypsin and phospholipids in the BALF were
      dose-dependently increased. Also serum α1-antitrypsin activity was
      significantly increased. Superoxide dismutase activity in the BALF, albumin
      and creatinine content were significantly increased in the lower dose group
003-6 Health-based Reassessment of Administrative Occupational Exposure Limits
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<pre>      only. On histopathology of the lungs, diffuse panbronchiolitis-like obstructive
      changes were observed in the group exposed to 11.5 mg/m3. The authors
      concluded that no NOAEL was found in this study.
          Uemura et al. (Uem95) exposed groups (n=10) of male ICR mice to 5.8
      mg/m3 (5 ppm) diborane for 6 hours/day, 5 daysweek for 2 and 4 weeks. The
      mice were killed on the day after final exposure. In this study the authors
      observed lymphoid hyperplasia in the perivascular and peribronchial areas, and
      infiltration of macrophage and plasma cells into the alveoli. In the mice
      exposed for 4 weeks, the lesions were more severe than in those exposed for 2
      weeks. The lesions consisted of hyperplasia and desquamation of Clara cells in
      the lungs. In the nasal cavity, the authors observed mucous exudate and
      inflammatory cells. No significant changes were seen in hematological (RBC
      and diff count of WBC) and serum biochemical (CPK, Ch-E, GOT, GPT, Al-p,
      BUN, Na and K) parameters. In this study, hepatic congestion was more
      frequent observed in the exposed groups. There were no histo-pathological
      changes in the brain, thyroid gland, thymus, heart, spleen and kidney.
          Nomiyama et al. (Nom95a) also exposed groups (n=10) of male ICR mice
      to diborane concentrations of 0.2 mg/m3 (0.2 ppm) or 0.8 mg/m3 (0.7 ppm) for
      6 hours/day, 5 days/week, for 2 or 4 weeks. No significant differences in
      behavior or external appearance between the control and exposed mice were
      seen. Lung weight was significantly greater in mice exposed to 0.8 mg/m3
      during 2 weeks. A slight dose-related infiltration of polymorphous neutrophils,
      mainly in the peribronchiolar region, was observed in mice exposed to 0.2 or
      0.8 mg/m3 diborane for 2 or 4 weeks. The authors concluded that for subacute
      exposure of mice 0.2 mg/m3 diborane was no longer a NOAEL. The committee
      suggests to appoint this level as the lowest observed adverse effect level
      (LOAEL) in mice.
          Nomiyama et al. (Nom96) again studied the effects of inhalation of
      diborane in groups of male Wistar rats (n=12) at levels of 0.13 or 1.1 mg/m3
      (0.11 and 0.96 ppm, respectively), 6 hours/day, 5 days/week, for 8 weeks. No
      significant differences were found between the exposed groups and control
      group in behavior, external appearance, body weight and histopathology of the
      lung. Examination of the BALF revealed that the percentage of neutrophils
      increased in a dose-dependent manner, whereas the percentage of macrophages
      was decreased in rats exposed to 1.1 mg/m3. Total and individual phospholipids
      in BALF was increased in rats exposed to 1.1 mg/m3. Also dose-dependent
      increases were found on the α1-AT and SOD activities in serum. The results of
      this study indicate a LOAEL of 0.13 mg/m3 in rats for effects on the lung.
003-7 Diborane
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<pre>          Krakow (Kra53) reported that rats exposed to an average concentration of
      2.3 mg/m3 (2 ppm) for a period of 1 to 4 days (6 hours/day), showed no
      significant changes in the organs examined. But exposure to 6 mg/m3 (5.2
      ppm) diborane, 6 hours/day, 5 days/week, for 2 to 3 weeks showed pulmonary
      damage. The number of animals studied was not reported. Pathological
      pulmonary changes already occurred in rats exposed to an average of 2.5
      mg/m3 (2.2 ppm) after one to four weeks of exposure.
          No data on long-term exposure, mutagenicity, genotoxicity and
      carcinogenicity have been found.
      Reproduction toxicity
      Nomiyama et al. (Nom96) reported no effects on the testes (sperm counts and
      sperm head abnormalities) after groups of rats (n=12) inhaled 0.13 or 1.10
      mg/m3 diborane, 6 hours/day, 5 days/week, for 8 weeks.
          No other data on reproduction toxicity have been found.
7     Existing guidelines
      The current administrative occupational exposure limit (MAC) of diborane in
      the Netherlands is 0.1 mg/m3 (0.1 ppm), 8 h TWA.
          Existing occupational exposure limits for diborane in some European
      countries and in the USA are summarized in the annex.
8     Assessment of health hazard
      The target organs of occupational exposure to diborane are the upper
      respiratory tract and the lungs as observed from human data and in animal
      experiments. Effects on the central nervous system (CNS) as reported in human
      case-reports are probably due to contamination with other boron hydrides like
      pentaborane and decaborane that are known for CNS effects (Loe57, Sch58).
      The human data do not allow the establishment of an health-based
      occupational exposure limit.
          The available animal data only concern acute and subacute studies. From
      these studies the following no observed adverse effect levels (NOAELs) and
      lowest observed adverse effect levels (LOAELs) for effects of diborane on the
      respiratory tract of rodents have been found:
          NOAEL in mice of 1.2 mg/m3 after 8 h exposure period (Nom95a);
003-8 Health-based Reassessment of Administrative Occupational Exposure Limits
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<pre>          LOAEL in rats of 1.2 mg/m3 after 4 h exposure period (Nom95b);
          LOAEL in mice of 0.2 mg/m3 after exposure for 6 hours a day, 5 days a
          week, for 4 weeks (Nom95a);
          LOAEL in rats of 0.13 mg/m3 after exposure for 6 hours a day, 5 days a
          week, for 8 weeks (Nom96).
      In a single subacute inhalation study in rats no effect of diborane on the testes
      was reported (Nom96). No further data on reproduction toxicity of diborane
      have been found.
          No data on long-term exposure, mutagenicity, genotoxicity and
      carcinogenicity of diborane were found.
          The committee takes the LOAEL of 0.13 mg/m3 for lung effects in the
      subacute rat study (Nom96) as a starting point. Since the effects induced by
      diborane are local rather than systemic, the committee considers an assessment
      factor for interspecies variation unneccessary. Application of an overall
      assessment factor of 9 to account for starting from a LOAEL and for
      intraspecies variation, results in a preferred value of 0.01 mg/m3.
      The committee recommends a health-based occupational exposure limit for
      diborane of 0.01 mg/m3 (0.01 ppm), as an 8 h time weighted average (TWA).
      References
ACG96 American Conference of Governmental Industrial Hygienists (ACGIH). TLVs and other occupational
      exposure values - 1996 (CD ROM, version 1.7-s4 02/01/95). Cincinnati OH, USA: ACGIH 1996.
ACG00 American Conference of Governmental Industrial Hygienists (ACGIH). 2000 TLVs and BEIs.
      Threshold limit values for chemical and physical agents. Biological Exposure Indices. Cincinnati OH,
      USA: ACGIH, 2000.
Arb96 Arbejdstilsynet. Exposure limit values for substances and materials. Copenhagen, Denmark: The
      Working Environment Service: Instruction no. 3.1.0.2. 1996.
AIH89 American Industrial Hygiene Association (AIHA), In: Odor thresholds for chemicals with established
      occupational health standards, 1989, Akron.
Com53 Comstock CC, Oberst FW. The median detectable concentration of diborane, pentaborane and
      decaborane by odor for man. Chemical Corps Medical Laboratories Research Report No. 206, Army
      Chemical Center, 1953.
Com54 Comstock CC, Feinsilver L, Lawson LH, Oberst FW. Inhalation toxicity of diborane in dogs, rats and
      guinea pigs. Chemical Corps Medical Laboratories Research Report No.258, Army Chemical Center,
      1954.
003-9 Diborane
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<pre>Cor68  Cordasco EM, Kosti H, Cooper R. Non-cardiac pulmonary edema in industry: newer aspects. Ind Med
       Surg 1968; 37: 603-8.
Cor73  Cordasco EM, Stone FD. Pulmonary edema of environmental origin. Chest 1973; 64: 182-5.
DFG99  Deutsche Forschungsgemeinschaft (DFG): Senatskommission zur Prüfung gesundheitsschädlicher
       Arbeitsstoffe. MAK- und BAT-Werte-Liste 1999. Maximale Arbeitsplatzkonzentrationen und
       biologische Arbeitsstofftoleranzwerte. Weinheim, FRG: VCH Verlagsgesellschaft MBH, 1999
       (Mitteilung 35).
HSE99  Health and Safety Executive (HSE). EH40/99 Occupational exposure limits 1999. Sudbury (Suffolk),
       England: HSE Books, 1999.
IPC93  International Programme on Chemical Safety - European Communities. International Chemical Safety
       Cards, diborane, ICSC: 0432.
Kra53  Krackow EH. Toxicity and health hazards of boron hydrides. Arch Ind Hyg Occup Med 1953; 8:
       335-9.
Kun56  Kunkel AM, Murtha EF, Oikemus AH, Stabile DE, Saunders JP, Wills JH. Some pharmacologic
       effects of diborane. Arch Ind Health 1956; 13: 346-51.
Low57  Lowe HJ. Boron hydride (borane) intoxication in man. AMA Arch Ind Health 1957; 16: 525-33
NBO96  National Board for Occupational Safety and Health. Occupational exposure limit values. Solna,
       Sweden: NBOSH, 1996; Ordinance AFS1996/2.
Nom95a Nomiyama T, Omae K, Uemura T, Nakashima H, Takebayashi T, Ishizuka C et al. No-observed-effect
       level of diborane on the respiratory organs of male mice in acute and subacute inhalation experiments. J
       Occup Health 1995; 37: 157-60.
Nom95b Nomiyama T. Inhalation toxicity of diborane in rats assessed by bronchoalveolar lavage examination.
       Arch Toxicol 1995; 70: 43-50.
Nom96  Nomiyama T, Omae K, Ishizuka C, Hosada K, Yamano Y, Nakashima H et al. Evaluation of the
       subacute pulmonary and testicular inhalation toxicity of diborane in rats. Toxicol Appl Pharmacol
       1996; 138: 77-83.
Rou59  Roush Jr GR. The toxicology of boranes. J Occup Med 1959; 1: 46-52.
Sch58  Schechter WH. Toxicity of high-energy fuels. AMA Arch Ind Health 1958; 17: 362-6.
SZW00  Ministerie van Sociale Zaken en Werkgelegenheid (SZW). Nationale MAC-lijst 2000. The Hague, the
       Netherlands: Servicecentrum Sdu Uitgevers, 2000.
Tre91  Treinen KA, Chapin RE. Development of testicular lesions in F344 rats after treatment with boric acid.
       Toxicol Appl Pharmacol 1991; 107: 325-35.
TRG00  TRG 900: Grenzwerte in der Luft am Arbeitsplatz; Technische Regeln für Gefahrstoffe; B Arb Bl
       2000; 2.
Uem95  Uemura T, Omae K, Nakashima H, Sakurai H, Yamazaki K, Shibata T et al. Acute and subacute
       inhalation toxicity of diborane in male ICR mice. Arch Toxicol 1995; 69: 397-404.
003-10 Health-based Reassessment of Administrative Occupational Exposure Limits
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<pre>             Annex
Occupational exposure standards for diborane in various countries.
country                        occupational                        time-weighted      type of exposure notea      lit refb
-organisation                  exposure limit                      average            limit
                               ppm             mg/m3
The Netherlands
-Ministry                      0.1             0.1                 8h                 administrative              SZW00
Germany
-AGS                           0.1             0.1                 8h                                             TRG00
-DFG MAK-Kom.                  -               -                                                                  DFG99
Great-Britain
-HSE                           0.1             0.12                8h                 OES                         HSE99
Sweden                         -               -                                                                  NBO96
Denmark                        0.1             0.1                 8h                                             Arb96
USA
-ACGIH                         0.1             0.11                8h                 TLV                         ACG00
-OSHA                          0.1             0.1                 8h                 PEL
-NIOSH                         0.1             0.1                 10 h               REL
European Union
-SCOEL
a
     S = skin notation; which means that skin absorption may contribute considerably to body burden; sens = substance can
     cause sensitisation
b
     Reference to the most recent official publication of occupational exposure limits
003-11       Diborane
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<pre>003-12 Health-based Reassessment of Administrative Occupational Exposure Limits</pre>

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<br><br>